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Vagus Nerve Stimulation

Phase 1

Congestive Heart Failure | Unknown | Cardiovascular |LivaNova PLC|Last Updated: Feb 19, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Vagus Nerve Stimulation · 1 trial · 1 indication

Phase 1 1
NCT01823887Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) StudyCongestive Heart Failure
COMPLETED60 Analytics
PHASE1COMPLETED
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study
Congestive Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

Cardiac Function
6 months

Left ventricular end-systolic volume (LVESV) and ejection fraction (EF)

Adverse Events
6 months

Incidence of procedure and device-related complications

Secondary Endpoints

Functional Status
6 months
Quality of Life
6 months
Autonomic Function
6 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Left Sided StimulationEXPERIMENTALLeft cervical Vagus Nerve Stimulation (VNS)
Right Sided StimulationEXPERIMENTALRight Cervical Vagus Nerve Stimulation (VNS)

Interventions

NameTypeDescription
Vagus Nerve Stimulation (VNS)DEVICEElectrical Stimulation of the Vagus Nerve
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with reduced EF and dilated hearts

Countries:India
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Frequently asked questions about Vagus Nerve Stimulation

What is Vagus Nerve Stimulation used for in Congestive Heart Failure?

Vagus Nerve Stimulation is an investigational therapy being studied for the treatment of Congestive Heart Failure. It involves stimulating the vagus nerve to potentially enhance myocardial function in patients with this condition. The therapy is currently in Phase 1 clinical development and has not yet been approved by regulatory authorities.

Who makes Vagus Nerve Stimulation?

Vagus Nerve Stimulation is being developed by LivaNova PLC, a company traded on the stock exchange under the ticker symbol LIVN. LivaNova is conducting clinical research to evaluate this therapy for the treatment of Congestive Heart Failure.

What phase is Vagus Nerve Stimulation in?

Vagus Nerve Stimulation is in Phase 1 clinical development for the treatment of Congestive Heart Failure. It is an investigational therapy, meaning it has not yet received regulatory approval and is still being evaluated in clinical trials to assess its safety and potential efficacy.

What clinical trials is Vagus Nerve Stimulation in?

Vagus Nerve Stimulation has been studied in a completed clinical trial with the identifier NCT01823887, titled 'Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study.' This Phase 1 trial enrolled 60 participants with Congestive Heart Failure and was conducted in India.

Is Vagus Nerve Stimulation the same as ANTHEM-HF?

Vagus Nerve Stimulation is not the same as ANTHEM-HF. ANTHEM-HF is the name of a specific clinical trial, formally known as the 'Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure Study,' which evaluates Vagus Nerve Stimulation as an investigational treatment for Congestive Heart Failure.